REDI NURSE SYSTEM (RNS) STERILE WATER FOR IRRIGATION— 510(k) K952395
Substantially EquivalentContour Fabricators of Florida, Inc.
FDA 510(k) clearance K952395 for REDI NURSE SYSTEM (RNS) STERILE WATER FOR IRRIGATION, Substantially Equivalent on 1995-08-15. Applicant: Contour Fabricators of Florida, Inc..
Clearance details
- Applicant
- Contour Fabricators of Florida, Inc.
- Product code
- Code BSY
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- St. Petersburg, FL, US
Adverse events under product code BSY
product code BSY- Death
- 3
- Injury
- 155
- Malfunction
- 959
- Total
- 1,117
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.